Lumicell Announces New Category III CPT® Code for Intraoperative Fluorescence Imaging Margin Assessment in Support of Market Launch
July 15 2024 - 8:30AM
Business Wire
Add-on CPT code granted following U.S. FDA
approval of LUMISIGHT™ (pegulicianine) and Lumicell™ DVS, together
referred to as LumiSystem™, with commercial availability in Q4
2024
Lumicell, Inc., a privately held company focused on developing
innovative fluorescence-guided imaging technologies for cancerous
tissue detection during surgery, today announced the American
Medical Association has granted a Category III, Current Procedural
Terminology (CPT) add-on code 0945T specifically for intraoperative
fluorescence imaging margin assessment following breast cancer
lumpectomy.3 The new CPT code is expected to become effective on
Jan. 1, 2025.
The purpose of CPT coding is to provide a uniform language that
accurately describes medical, diagnostic, and testing services for
reliable nationwide communication among physicians and other
healthcare providers, patients, and third parties such as
payors.
The granting of this add-on code will allow physicians to report
their usage of LUMISIGHT™ and Lumicell™ DVS, together referred to
as LumiSystem™, to help payors collect claims data for improved
access. “This is an important milestone for providers who offer
this new adjunctive treatment option to their patients with breast
cancer undergoing lumpectomy,” said Howard Hechler, President and
Chief Operating Officer, Lumicell. “The Category III code will
enable wider commercial access to LumiSystem by facilitating future
reimbursement from US government payors and commercial health
insurance companies.”
Clinical studies have shown that up to 36% of patients have
re-excisions due to positive margins and 14% of patients with
negative margins after lumpectomy have cancer remaining.1 With 84%
diagnostic accuracy, LumiSystem is the first and only system that
enables surgeons to scan inside the breast cavity, in real-time, to
detect and resect residual cancer that may have otherwise been left
behind.2
“This new CPT code demonstrates positive momentum towards
improving patient access to LumiSystem, which will have significant
impact on breast cancer surgical outcomes for patients,” said Peter
Blumencranz, MD, Medical Director, BayCare Oncology Service Line
and The Comprehensive Breast Care Center of Tampa Bay.
LumiSystem will be commercially available in Q4 of this year.
Please visit www.LumiSystem.com to learn more about LUMISIGHT and
Lumicell DVS.
About Lumicell Inc.
Lumicell is a privately held company focused on enabling a more
complete resection of cancer by advancing the development and
commercialization of its innovative fluorescence guided surgery
technology. The company’s lead products are LUMISIGHT™
(pegulicianine) and Lumicell™ DVS which are designed for use in
combination to illuminate cancerous tissue within the breast cavity
during the initial lumpectomy procedure, as an adjunct to the
Standard of Care. Lumicell’s proprietary, pan-oncologic optical
imaging agent, LUMISIGHT, is also being explored for further
development across a wide variety of solid tumor indications. For
more information, please visit www.Lumicell.com and follow the
company on Facebook, X, and LinkedIn.
Indications for Use
LUMISIGHT, an optical imaging agent, and Lumicell DVS, a
fluorescence imaging device, are indicated for fluorescence imaging
in adults with breast cancer as an adjunct for the intraoperative
detection of cancerous tissue within the resection cavity following
removal of the primary specimen during lumpectomy surgery.
Important Safety Information
What is the most important information I should know about
LUMISIGHT?
LUMISIGHT may cause serious hypersensitivity reactions,
including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%)
of patients in clinical studies. Tell your doctor if you have any
history of hypersensitivity reactions to pegulicianine or to
contrast media or products containing polyethylene glycol
(PEG).
Your healthcare provider should have emergency resuscitation
drugs, equipment, and trained personnel available during use of
LUMISIGHT. Healthcare providers should monitor all patients for
hypersensitivity reactions and if one is suspected, immediately
discontinue the injection and initiate appropriate therapy.
What other safety information should I know about
LUMISIGHT?
- Risk of Misdiagnosis: The absence of a signal in surgery
does not rule out cancer. Additionally, a positive signal may be
seen in non-cancerous tissue.
- Interference from Dyes Used for Sentinel Lymph Node
Mapping: Your healthcare provider should avoid using dyes
before imaging with LUMISIGHT.
What are the most common side effects of LUMISIGHT?
The most common side effects (≥1%) include hypersensitivity and
an abnormal color in urine.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit MedWatch or call
1-800-FDA-1088. Please see full Prescribing Information, including
Boxed Warning.
What is the most important information I should know about
Lumicell DVS?
- Adjunctive use: Lumicell DVS is for use as part of the
lumpectomy procedure and is not a replacement for the standard of
care procedures and pathology. Your healthcare provider must be
trained on proper use of the Lumicell DVS, and breast conserving
surgery prior to performing any procedures.
- Risk of Misdiagnosis: The absence of a signal in surgery
does not rule out cancer. Additionally, a positive signal may be
seen in non-cancerous tissue.
- Interference from Dyes Used for Sentinel Lymph Node
Mapping: Your healthcare provider should avoid using dyes
before imaging with LUMISIGHT.
- Tissue perforation or damage: During the procedure, your
healthcare provider should avoid excessive pressure or torque with
the handheld probe while inside the cavity as it can cause tissue
perforation or damage.
- Infection risk: To avoid infection risk, the reusable
handheld probe and cables should be properly and completely
disinfected and reprocessed after each use. Your healthcare
provider should also ensure proper use of the sterile, single-use
probe cover.
- Eye discomfort: Avoid direct eye exposure to handheld
light probe as it may cause pain.
Please see the LUMISIGHT Prescribing Information, including
Boxed Warning, and Lumicell DVS Instructions for Use. For complete
product information, visit www.LumiSystem.com.
© 2024 Lumicell Inc. All Rights Reserved.
MKT00246
1 Dupont, et al., Ann Surg 2021; 273(5): 876-881 2 Smith, et
al., NEJM Evidence 2023; 2(7) 3
https://www.ama-assn.org/system/files/cpt-category3-codes-long-descriptors.pdf
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